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Non‐Biological Complex Drugs


Warning letter causes delays for follow-on glatiramer acetate posted 17/03/2017

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 17 February 2017 that Sandoz’s contracted fill/fin...


Is the EU ready for non-biological complex drug products? posted 03/03/2017

The definition of non-biological complex drugs (NBCDs) is not officially recognized, and there is no corresponding term, in t...


US guidelines for follow-on NBCDs posted 29/07/2016

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Polices & Legislation

FDA to set up abbreviated pathway for complex products posted 21/10/2016

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and...


Challenges in the assessment of ophthalmic emulsions posted 18/11/2016

Challenges in the assessment of the similarity or equivalence of ophthalmic emulsions as non-biological complex drugs (NBCDs)...